← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K962810 # GREAT HANDS MITTS (K962810) _Heelbo, Inc. · FMQ · Oct 9, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K962810 ## Device Facts - **Applicant:** Heelbo, Inc. - **Product Code:** [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ.md) - **Decision Date:** Oct 9, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital - **Attributes:** Therapeutic, Pediatric ## Indications for Use Great Hands Mitts hand restraints are worn like gloves. The mitts are intended to prevent patients from grasping or pulling out catheters, I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others. ## Device Story Great Hands Mitts are wearable hand restraints designed to prevent patients from grasping or pulling out medical lines (catheters, I.V. tubes) or causing self-inflicted injury. The device consists of a cotton-covered mitt filled with polyester, featuring a mesh side with sewn-in finger lanes and a Velcro wrist strap with a D-Ring fastener. Used in clinical settings, the mitts are worn like gloves. They function as a physical barrier to limit hand dexterity and grasping capability. The device benefits patients by maintaining the integrity of life-sustaining medical lines and preventing physical harm. ## Clinical Evidence No clinical data. The device relies on a history of safe use of component materials in the garment industry and the absence of reported skin irritation complaints. ## Technological Characteristics Materials: cotton cover, polyester fill, mesh fabric, Velcro strap, D-Ring fastener. Form factor: glove-like restraint available in adult, infant, toddler, and youth sizes. Non-powered, mechanical restraint. ## Regulatory Identification A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others. ## Predicate Devices - Great Hands Mitts ([K962810](/device/K962810.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651 312/489-7711 Telex RCA 297-248 800/323-5444 Fax 312/489-7744 K962810 OCT - 9 1996 Heelbo, Inc. Great Hands Mitts ## Safety and Effectiveness Summary ### 1. Submitter's name, Address and Contact Person | Submitter | Contact Person | | --- | --- | | Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL | Joseph S. Tokarz, Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Ph: (847)680-2849, Fax: (847)918-3860 | Date Summary Prepared - July 15, 1996 ### 2. Name of Device: Great Hands Mitts ### 3. Name of Predicate Device(s) Great Hands Mitts ### 4. Description of Device Great Hands Mitts are hand restraints that are worn like gloves. The cotton covered mitt is filled with polyester and is covered with a mesh material on one side. The glove-like finger lanes are sewn into the mesh material and a Velcro wrist strap with a D-Ring loop fastener helps secure the glove in place. The mitts are intended to prevent patients from grasping or pulling out catheters, I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others. The Great Hands Mitts are available in one size, and three colors to accommodate adult hands and three sizes, three colors to accommodate infants, toddlers and youths. Below is the listing of stock numbers and availability. | Stock Number | Description | Color | | --- | --- | --- | | 1000, 1000HP, 1000N | adult | white, hot pink, navy | | 1110, 1110HP, 1110N | infant | white, hot pink, navy | | 1120, 1120HP, 1120N | toddler | white, hot pink, navy | | 1130, 1130HP, 1130N | youth | white, hot pink, navy | Page 18 {1} Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651 312/489-7711 Telex RCA 297-248 800/323-5444 Fax 312/489-7744 Heelbo, Inc. Great Hands Mitts ## 5. Statement of Intended Use Great Hands Mitts hand restraints are worn like gloves. The mitts are intended to prevent patients from grasping or pulling out catheters, I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others. ## 6. Statement of Technological Characteristics of the Device Great Hands Mitts are hand restraints that are worn like gloves. The cotton covered mitt is filled with polyester and is covered with a mesh material on one side. The glove-like finger lanes are sewn into the mesh material and a Velcro wrist strap with a D-Ring loop fastener secures the glove in place. The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency’s labeling requirements set forth in the draft “Guidance on the Content of Premarket Notification [501(k)] Submissions for Protective Restraints” dated December 1995. ## 7. Biocompatibility Assessment The subject devices are identical in component materials to the predicate devices. The suppliers of the materials use in the fabrication of these devices have stated that there is a history of safe use of their materials in the clothing and garment industry. In addition, Heelbo, Inc., is not aware of any reports or complaints of skin irritation associated with these materials. ## 9. Conclusion Based upon the information presented above it is concluded that the Heelbo Great Hands Mitts are safe and effective for their intended use and are substantially equivalent to the predicate device. Page 19 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K962810](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K962810) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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